2018 年 9 月改版
"安定伏"裂解型流感疫苗 [一般版]
AdimFlu-S 衛署菌疫製字第 000113 號
【本 質】
本劑係含流感病毒 HA 抗原，為澄清或微白色懸浮液。本劑使用之病毒株及每 0.5 mL 疫苗中 HA 抗原含量為：
A/Michigan/45/2015(H1N1)pdm09-like virus
A/Singapore/GP1908/2015 (Reassortant IVR-180)…...…………..…………...15μg/0.5mL A/Singapore/INFIMH-16-0019/2016 (H3N2)-like virus
A/Singapore/INFIMH-16-0019/2016 (Reassortant IVR-186)………...…...15μg/0.5mL B/Colorado/06/2017-like virus
B/Maryland/15/2016 (Reassortant NYMC BX-69A).………...…...……….………...…15μg/0.5mL
此疫苗依從世界衛生組織（WHO）為 2018/2019 年（北半球）流感季節所建議之病毒株。
pH6.8-8.0，滲透壓比（對生理食鹽水比）約 1。
【製法概要】
本劑係將流感病毒株接種於發育中的雞蛋尿膜腔內，培養後，抽出含病毒之尿膜腔液，經蔗糖密度梯度離心法將病 毒粒子分離及濃縮後，以乙醚將病毒粒子分解後，取其 HA 片段。以福馬林不活化後，用磷酸緩衝溶液稀釋調製，
使溶液中含有規定量之病毒株 HA。
磷酸緩衝溶液含有以下賦形劑成分：氯化鈉 (Sodium chloride)、磷酸氫二鈉（Disodium hydrogen phosphate）、磷酸 二氫鉀（Potassium dihydrogen phosphate）以及注射用水。本疫苗含有製程中會加入的微量甲醛(Formaldehyde)和聚 山梨醇酯 80(Polysorbate80)。
【適應症】
預防流感。
【用法用量】
通常採皮下或肌肉注射。
接種量：(1) 0.5 歲以上未滿 3 歲兒童：一劑 0.25mL。
(2) 3 歲以上兒童及成人：一劑 0.5mL。
未滿 9 歲兒童，若先前未曾注射過流感疫苗者，需接種 2 次，且間隔至少 4 週。
針 筒：若使用預先填充之 0.5mL 針筒為 0.5 歲以上未滿 3 歲幼兒注射時，只需要一半的劑量(0.25mL)，方法是：
將膠塞推至記號邊緣，讓一半劑量排除，而剩下的劑量則用以注射。
【注意事項】
1.一般注意事項：
被接種者在接種前必須由醫師先做問診，檢溫及診察（視診、聽診等）健康狀態的調查。
2.不適接種者：
先前接種本疫苗或對本疫苗任何成分曾發生嚴重過敏反應者。
3.注意事項：
(1) 發燒或正患有急性中重度疾病者，宜待病情穩定後再接種。
(2) 出生未滿 6 個月不適合接種。
(3) 先前接種本疫苗六週內曾發生格林-巴利症候群(Guillain-Barré syndrome, GBS)者。
(4) 已知對「蛋」之蛋白質有嚴重過敏者，可在門/住診由熟悉處理過敏症狀之醫事人員提供接種，並於接種後觀 察 30 分鐘，無不適症狀再離開。
(5) 其他經醫師評估不適合接種者。
4.妊婦之接種：
已有超過2000位孕婦接種季節性流感疫苗的研究報告顯示並無任何胎兒產生不良影響。但本疫苗並無針對動物生 殖系統的研究亦無接種於孕婦是否傷害胎兒或影響生殖能力的報告。由於孕婦是流感併發症的高危險族群且可在 接種疫苗後提供胎兒保護力，除孕婦已知（或曾有）對本劑成分有過敏者外，建議孕婦應依流感流行的適用性優 先施打本疫苗。
5.由於本疫苗並未對免疫系統缺損和慢性病患族群評估其血清免疫效果，因此其對該等病患之效果與安全性並不清 楚。
6.相互作用：與免疫抑制劑（Cyclosporin 製劑等）等之關係：
對於使用免疫抑制製劑者、特別是長期或大量使用者，可能得不到預期之效果。
7.不良反應：
(1)安定伏上市前臨床試驗中曾發生的不良反應：
根據臨床試驗之不良反應發生頻率統計:
極常見(≧1/10)；常見(≧1/100，＜1/10)；不常見(≧1/1000，＜1/100) 18 歲以上成人，疫苗注射後第 7 天追蹤之局部與全身性不良反應發生率如下:
分類 極常見 常見 不常見
一般症狀與注射部位症狀 疼痛/痠痛 腫脹、發紅、手臂活動困難 瘀斑
呼吸系統、胸部及縱膈疾病 鼻塞、咳嗽、喉嚨痛、胸悶 呼吸窘迫
骨骼肌與結締組織症 肌肉疼痛、全身無力
神經系統症狀 頭痛
眼疾 眼睛發紅
胃腸消化系統 噁心、嘔吐
皮膚及皮下組織 臉部水腫
(2)季節性流感疫苗上市後曾通報以下不良反應：
血液及淋巴系統症狀：血小板減少、淋巴結病 胃腸道症狀：腹痛、吞嚥困難、肝機能障礙 新陳代謝症狀：食慾不振
全身性症狀及注射部位症狀：無力、類流感症狀、注射部位嚴重紅腫 肌肉骨骼及結締組織疾病：關節炎、背痛、四肢疼痛
神經系統症狀：神經系統異常(如麻痺相關症狀)、眩暈、嗜眠、暈厥、神經痛、步態異常、感覺遲鈍、感覺異 常、顏面神經麻痺、痙攣、格林-巴利症候群(Guillain-Barré syndrome, GBS)、颤抖、急性散在性 腦脊髓炎(Acute disseminated encephalomyelitis, ADEM)
血管症狀：蒼白、潮紅、血管炎、暫時性腎臟問題(罕見)
過敏反應：休克、氣喘、史蒂文森氏-強生症候群、毒性表皮壞死溶解症、皮膚出疹 (3)前一年度流感季節之上市後安全性研究：
與再前一年度之上市後安全研究數據相比較，無出現異常安全性警訊。
8.接種時的注意事項：
(1)接種前，用酒精消毒接種部位。應避免在同一部位反覆注射。
(2)接種時應確認注射針前端未插入血管內。
(3)每位被接種者應使用新的注射針筒。
(4)告知被接種者或其照顧者在接種當日應避免過度運動，並保持接種部位的清潔。另應留意接種後的健康狀況，
如有任何不適或異常的身體變化，高燒、痙攣等異常症狀時，應促其迅速找醫師診察。
【使用上的注意】
1.誤將本劑凍結時，因有品質變化之虞，不可使用。
2.從冷藏庫取出時，待回復到室溫後，振盪混勻後才使用。
3.使用前必須確認沒有異常的混濁、呈色、異物和其他的異常。
4.目前尚無相關臨床試驗數據或研究報告，因此不建議將本劑與其他廠牌季節性流感疫苗混用。
【預充填針筒劑型使用上的注意】
該劑型為無菌包裝 1 人份，絕對不可破壞針筒結構而再使用其中的藥劑。
【瓶裝劑型使用的注意】
1.建議使用 1mL 注射針筒和 24~ 26 號針頭抽取及施打疫苗。
2.容器的栓塞和其周圍以酒精消毒後，插入注射針吸取所需要藥量於注射筒內，均應遵守無菌技術操作，勿將栓塞 打開或將藥劑轉移至其他容器使用。
3.一旦以注射針首次插入後，該瓶藥劑應依規定溫度儲存，並於 24 小時內使用完畢。
本藥須由醫師處方使用
【儲存、有效期限】
1.遮光儲存在 2~8℃，避免凍結。
2.有效期限請見外盒標示。
【包裝】
針筒包裝：0.5mL/syringe (1 人份)
【製造廠】
國光生物科技股份有限公司
廠址：42743 台中市潭子區潭興路一段 3 號 電話：04-25381220 傳真：04-25382105
Date of last revision: September 2018
Product Name: AdimFlu-S [General]
Number of product-license Taiwan: DOH-BM-000113 Composition:
This vaccine, a clear or slightly whitish opaque suspension, contains purified influenza virus HA antigen.
One dose of 0.5 mL of vaccine contains:
A/Michigan/45/2015(H1N1)pdm09-like virus
A/Singapore/GP1908/2015 (Reassortant IVR-180)…………...…………..…………...15μg/0.5mL A/Singapore/INFIMH-16-0019/2016 (H3N2)-like virus
A/Singapore/INFIMH-16-0019/2016 (Reassortant IVR-186) ...…..….….…....15μg/0.5mL B/Colorado/06/2017-like virus
B/Maryland/15/2016 (Reassortant NYMC BX-69A)..………...…...……….………...15μg/0.5mL
The abovementioned virus strain follows the WHO-recommended composition of influenza virus vaccines for use in the 2018-2019 influenza season in the northern hemisphere.This vaccine preparation has a pH of 6.8-8.0 and an osmolarity ratio to normal saline of approximately 1.
Description:
The influenza virus strain is inoculated into the allantoic cavity of developing embryonated chicken egg. After incubation, the virus-containing allantoic fluid is collected and sucrose density gradient centrifugation is performed to isolate and concentrate the virus particles. Ether is added to lyse the virus particles and the resulting hemagglutinin (HA) fraction is recovered, inactivated by formalin, and diluted with a phosphate buffered solution to formulate a final suspension containing the required amount of HA of the virus strain. A phosphate buffered solution contains the following excipients – sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate and water for injection. The vaccine may contain traces of formaldehyde and polysorbate 80, which are added during the vaccine manufacturing process.
Indication :
This vaccine is intended for use in the prevention of influenza.
Administration and Dosage:
This vaccine is administered subcutaneously or intramuscularly.
Dosage: (1) For children of age 6 months to age < 3, one dose of 0.25 mL of vaccine is injected.
(2) For children of age ≥ 3 and for adults, one dose of 0.5 mL of vaccine is injected.
For children of age < 9 previously unvaccinated with any seasonal flu vaccine, two doses should be administered.
Each dose should be administered at least 4 weeks apart.
Use of pre-filled syringe packaging:
If the vaccination is to be given to a child younger than the age of 3, only half of the dose (i.e., 0.25 mL) of a pre-filled 0.5 mL syringe is required. Discard half of the content of the syringe and use the rest for injection.
Precautions:
1. Before vaccination, the recipient has to be enquired and visually examined, and an auscultation performed if necessary, to check the health status.
2. If the recipient shows any of the following symptoms, she or he should NOT be vaccinated.
Known severe allergic to one of the components of the vaccine.
3. Precautions:
(1) Fever or acute moderate and severe disease, should be avoided for vaccination.
(2) Born less than 6 months.
(3) Guillain-Barré syndrome (GBS) has occurred within 6 weeks of following previous vaccination.
(4) Known have severe allergy to the protein of “eggs”can be vaccinated at the outpatient/inpatient clinic by a medical staff familiar with allergic symptoms. It’s recommended to check within 30 minutes after injection and leave without symptoms.
(5) Whoever assessed by physicians not suitable for vaccination.
4. Vaccination for pregnant women: Research study on more than 2,000 pregnant women given the seasonal influenza virus vaccine showed no adverse foetal effect. However, no report is available for this vaccine preparation with regards to research targeted to the animal reproductive system as well as to the effect on fetus or fertility of vaccinated pregnant women. Pregnant women belong to the high-risk group of the influenza complication and they can provide foetal protection after vaccination. It is therefore proposed that a pregnant woman should be given the priority of this vaccine injection unless she is allergic to the component(s) of the vaccine.
5. Vaccination for people with immunodeficiency and chronic diseases: The effect of this vaccine to people with
immunodeficiency and chronic diseases has not been tested, so the efficacy and safety of the vaccination is still uncertain.
6. Interactions: with relation to immuno-suppressants such as Cyclosporin. For individuals using immuno-suppressants, especially for long term or large quantity use, the expected effect of this vaccine may not be achieved.
7. Adverse reactions
(1) During clinical trials of AdimFlu-S, the following side effects have been observed:
Adverse reactions are listed according to the following frequencies:
Very common: ≥ 1/10 Common: ≥ 1/100 to < 1/10 Uncommon: ≥1/1,000 to < 1/100
In the clinical study that solicited local and systemic event within 7 days after vaccination in healthy subjects aged over 18 years the frequencies of adverse reactions is shown as follows:
System Organ Class Very common Common Uncommon
General disorders and
administration site conditions Pain/Soreness Swelling, Redness,
Decreased limb mobility Ecchymosis Respiratory, thoracic and
mediastinal disorders
Nasal congestion, Cough, Sore throat, Chest tightness
Respiratory distress Musculoskeletal and
connective tissue disorders Muscle aches, Malaise Nervous system disorders Headache
Eye disorders Eye redness
Gastrointestinal disorders Nausea, Vomiting Skin and subcutaneous tissue
disorders
Facial edema
(2)The following adverse reactions occurred after the vaccine came on the market:
Blood and lymphatic system disorders: Thrombocytopenia, Lymphadenopathy Gastrointestinal disorders: Abdominal pain, Dysphagia, Anhepatia
Metabolism and nutrition disorders: Lack of appetite
. General disorders and administration site conditions: Malaise, Influenza-like symptoms, Severe welling, Musculoskeletal and connective tissue disorders: Arthritis, Back pain,Pain of limbs
Nervous system disorders: Neurologic abnormality (Facial palsy symptoms), Dizziness, Somnolence, Syncope, Nerve pain, Abnormal gait, Facial palsy, Hypesthesia, Dysesthesia, Seizure, Guillain- Barre syndrome (GBS), shake, Acute disseminated encephalomyelitis (ADEM) Vascular disorders: Pale, Hot flashes, Vasculitis, Transient renal involvement (very rare)
Hypersensitivity: Shock, Asthma, Stevens-Johnson syndrome, Toxic epidermal necrolysis, Rash (3) Adverse reactions single detection of post authorization safety study (PASS) in the last years:
Comparing to the PASS in 2016-2017, there is no trend of a significant change in reactogenicity or other apparent safety signal noted in PASS 2017-2018.
8. Notes for vaccination
(1) The vaccination site should be disinfected with alcohol prior to injection. Avoid repeated injections at the same site.
(2) Be sure that the injection needle does not penetrate the blood vessel during the administration.
(3) A new injection needle has to be used for each recipient.
(4) Advise the recipient or his caretaker to avoid vigorous activities and maintain the cleanliness of the vaccination site on the vaccination day. Continue monitoring the recipient’s health condition after vaccination. If any discomfort or abnormality such as fever or seizure occurs, one should seek medical attention immediately.
Handling of the vaccine:
1. Do not freeze the product. If the vaccine is frozen by mistake, discard it due to the possibility of deterioration.
2. After taking out from the refrigerator, this vaccine has to be warmed up to the room temperature and mixed well before use.
3. Check the vaccine for abnormal cloudiness, color, foreign material and other anomaly; if any of these is present, discard the product.
4. Due to an absence of clinical data to support the interchangeability of seasonal flu vaccines, one should not complete the vaccination course with different brands of seasonal flu vaccines.
Handling of the product in prefilled syringe packaging:
Each syringe is aseptically packaged and for single dose only. Do not use the medicament contained inside once the needle structure has been destroyed or broken.
Handling of the product in vials:
1. The use of 1mL syringe and No. 24 to 26-gauge needle is recommended for extraction and injection of the vaccine.
2. After disinfecting the cap and the vial with alcohol, insert the needle to extract the desired amount of product into the syringe. Aseptic technique should be used to withdraw all doses. Never remove the rubber stopper from the vial or transfer the medicament to another container.
3. The remaining product in vials should be used within 24 hours once the stopper has been pierced. Between uses, store the vial between 2 oC and 8 oC. If unused, discard at the end of the 24 hour period.
This vaccine can only be administered with doctor’s prescription.
Storage and date of expiration:
1. Store this vaccine in a cool and dark place (2~8℃). Do not freeze.
2. The expiry date is stated on the external packaging.
Packaging:
Syringe: One-dose prefilled syringe (0.5mL)
Manufacturer: ADIMMUNE CORPORATION
No. 3, Sec. 1, Tanxing Rd., Tanzi Dist., Taichung City 42743, Taiwan Tel: 886-4-2538-1220 ; Fax: 886-4-2538-2105
